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Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. However, due to the depressive effect of Propofol on the respiratory system, this regimen is not without risk. Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak effect on the respiratory system. The pharmacological profile of Dexmedetomidine may be advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.
Atrial fibrillation (AF) is the most common arrhythmia. In symptomatic patients, electroanatomic mapping aided catheter ablation (CA) is an established therapeutic option. The intervention may last several hours, during which patients are required to lie as still as possible, as inadequate patient movements disturb the electroanatomic map, prolong the intervention and increase its complication risks. Therefore patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. Despite its wide use, this regimen is not without risk, as Propofol has a pronounced depressive effect on the respiratory system.
Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak respiratory depression. By reducing sympathetic activity it also reduces the stress response to an intervention. For these reasons, Dexmedetomidine is commonly used in intensive care units, where it has been shown to be well tolerated. Consequently, its range of application has been increasingly widened and good experience has been made with its use in transfemoral valve replacement procedures or gastroenterological interventions.
The pharmacological profile of dexmedetomidine may be also advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | Active agent: Propofolum (2,6-Diisopropylphenol). Route of administration: intravenous |
|
| Dexmedetomidine | Active Comparator | Active agent: Dexmedetomidinum ut Dexmedetomidini hydrochloridum. Route of administration: intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced via the continuous infusion of propofol using a target-controlled infusion (TCI) pump. The effect-site propofol concentration will be initially set to 1.5 µg/ml, unless the patient is already sedated by fentanyl. Subsequently, an effect-site propofol concentration of 1 µg/ml will be chosen adjusted stepwise (using steps of 0.3 µg/ml) to reach a target score of 2-3 on the MOAA/S scale. In case of pain fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint) |
| within 24 hours after completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Sedation-Emergent Adverse Events (Individual Safety Endpoints) | All single components of the primary endpoint | within 24 hours after completion of procedure |
| Other complications | Number of complications not related to sedation (cardiac tamponade, stroke/transient ischemic attack, pericardial effusion necessitating therapeutic intervention, bleeding necessitating therapeutic intervention, others) [number of events] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helge Servatius, MD | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, University Hospital Inselspital Bern | Bern | Canton of Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39085782 | Derived | Servatius H, Kueffer T, Erdoes G, Seiler J, Tanner H, Noti F, Haeberlin A, Madaffari A, Branca M, Dutschler S, Theiler L, Reichlin T, Roten L. Electrophysiological differences of randomized deep sedation with dexmedetomidine versus propofol. BMC Anesthesiol. 2024 Jul 31;24(1):263. doi: 10.1186/s12871-024-02647-x. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Dexmedetomidine | Drug | At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced with a loading dose of dexmedetomidine (0.8 µg/kg) over 10 minutes. The maintenance dexmedetomidine dose is adjusted to the appropriate sedation criteria for CA (0.4 µg/kg/h) and for a target score of 2-3 on the MOAA/S scale. In case of pain, additional fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion. |
|
| from start until end of ablation procedure |
| Opiod dose | Opiod dose required for analgesia [ug] | from start until end of ablation procedure |
| Procedure duration | Total duration of the procedure [minutes] | from start until end of ablation procedure |
| Fluoroscopy time | Duration of fluoroscopy [minutes] | from start until end of ablation procedure |
| General sedation efficacy: occurrence and number of shiftings | General sedation efficacy assessed by the occurrence and number of shiftings of the acquired 3D map due to patient movements, necessitating remapping [number of events] | from start until end of ablation procedure |
| Sedation depth | Depth of sedation assessed by the Modified Observer's Alertness/Sedation (MOAA/S) scale [mean score] | from start until end of ablation procedure |
| Blood pressure | Mean systolic, diastolic and mean blood pressure during sedation and mean drop of blood pressure (pre-procedural blood pressure minus mean blood pressure during sedation) [mmHg] | from start until end of ablation procedure |
| Heart rate | Mean heart rate during sedation and mean drop of heart rate (pre-procedural heart rate minus mean heart rate during sedation) [beats per minute] | from start until end of ablation procedure |
| Refractory period | Effective refractory period of the atria and atrioventricular node [ms] | from start until end of ablation procedure |
| Wenckebach point | Wenckebach point of the atrioventricular node [ms] | from start until end of ablation procedure |
| Arrhythmia inducibility | Rate of inducibility of supraventricular arrhythmias during pacing manoeuvres (number of successful/number of attempts) [%] | from start until end of ablation procedure |
| Patient satisfaction: Patient Satisfaction with Sedation Instrument (PSSI) [score] | Patient satisfaction as assessed by the Patient Satisfaction with Sedation Instrument (PSSI) [score] | within 24 hours after completion of procedure |
| Cardiologist satisfaction: Clinician Satisfaction with Sedation Instrument (CSSI) [score] | Cardiologist satisfaction as assessed by the Clinician Satisfaction with Sedation Instrument (CSSI) [score] | within 24 hours after completion of procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |